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Last Updated: November 19, 2019

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CLINICAL TRIALS PROFILE FOR FLUTICASONE PROPIONATE

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505(b)(2) Clinical Trials for Fluticasone Propionate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT00364442 Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics Completed GlaxoSmithKline Phase 1 2005-01-01 A new formulation of Fluticasone propionate/Salmeterol comparing a lower dose of fluticasone propionate and salmeterol was compared with concurrent administration of fluticasone propionate and salmeterol. Administration occurred over 14 days and tolerability, PK (pharmacokinetic) and PD (pharmacodynamic) measurements were performed.
New Combination NCT00497237 Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate Plus Formoterol vs Fluticasone Propionate Plus Salmeterol in the 6 Months Step Down Treatment of Asthma Completed Chiesi Farmaceutici S.p.A. Phase 3 2007-04-01 Asthma is a serious global health problem. People of all ages in countries throughout the world are affected by this chronic airway disorder that can be severe and sometimes fatal. The prevalence of asthma is increasing everywhere, especially among children.According to international guidelines, once control of asthma is achieved and maintained for at least 3 months, a gradual reduction of the maintenance therapy should be tried in order to identify the minimum therapy required to maintain control. This will help reduce the risk of side effects and enhance patient adherence to the treatment plan. Reduction of therapy in patients on combination therapy should begin with a reduction in the dose of inhaled glucocorticosteroid.1 The present study is designed to evaluate if patients with controlled asthma treated with FP 1000 mcg + salmeterol 100 mcg daily can be stepped down. Stepping-down will be attempted with two medications: a new combination of extrafine beclomethasone dipropionate 400 mcg + formoterol 24 mcg daily (test medication, Foster™) and, alternatively, fluticasone propionate 500 mcg + salmeterol 100 mcg daily(reference medication) without losing asthma control.If this hypothesis will be confirmed, the present study will demonstrate that asthma control can be maintained with less than half the dose of inhaled corticosteroid and with less medical costs. Given the aims of this study, the population to be monitored includes adult patients with moderate persistent asthma, which can be defined controlled according to the current guidelines under standard stabilised treatment. The intended treatment duration is therefore designed to ensure that good control of asthma is firmly achieved before stepping down the treatment (8 weeks run-in period), but also that the condition of the patients are followed long enough (24 weeks comparative treatment period) to ensure that a new stable condition is also obtained and properly monitored.
New Formulation NCT01255579 Effects on Small Airways of Two Long-term Extrafine Treatments in Asthma Completed Università degli Studi di Brescia Phase 4 2007-07-01 New formulations of extrafine particles of long acting beta-2 agonists+inhaled corticosteroids (LABA+ICS) are able to reach more peripheral regions of the lung. Objectives.The aim of this study was to assess the effect on small airways obstruction of long-term treatments with two different LABA+ICS combinations in asthma. Patients and methods.Ten subjects with moderate persistent asthma were enrolled. After a 4-week washout they were treated in a randomized cross-over design for 24 weeks with formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d. (FB) or salmeterol 50 mcg and fluticasone 250 mcg (diskus) b.i.d. (SF). At baseline and at the end of each period subjects underwent Asthma Control Test (ACT) and Pulmonary Function Testing. The N2 phase III slope and closing volume (CV) during single breath washout test, and DElta(Heliox-air)MEF50% were measured to assess changes on peripheral airways function.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Fluticasone Propionate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000577 Asthma Clinical Research Network (ACRN) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1993-09-01 This study will establish a network of interactive asthma clinical research groups to evaluate current therapies, new therapies, and management strategies for adult asthma.
NCT00000622 Childhood Asthma Research and Education (CARE) Network Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1999-09-01 The purpose of this study is to evaluate current and novel therapies and management strategies for children with asthma. The emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages.
NCT00071552 Efficacy of QVAR vs Flovent Diskus on Small Airways in Poorly Controlled Asthmatic Adolescents/Adult Patients Terminated Teva Branded Pharmaceutical Products, R&D Inc. Phase 4 2004-01-01 The primary objective of this study is to evaluate the effect of Beclomethasone dipropionate HFA on small airways compared to Fluticasone propionate powder for inhalation administered twice daily to poorly controlled asthmatics.
NCT00102765 Study Of Asthma In Patients Of African Descent Completed GlaxoSmithKline Phase 4 2004-11-01 This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate alone)
NCT00102882 Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate Completed GlaxoSmithKline Phase 4 2004-10-01 This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.
NCT00115492 Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations Completed GlaxoSmithKline Phase 4 2004-12-01 This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by FDA for use in patients with COPD.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Fluticasone Propionate

Condition Name

Condition Name for Fluticasone Propionate
Intervention Trials
Asthma 132
Pulmonary Disease, Chronic Obstructive 42
Chronic Obstructive Pulmonary Disease 15
Seasonal Allergic Rhinitis 15
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Condition MeSH

Condition MeSH for Fluticasone Propionate
Intervention Trials
Asthma 118
Lung Diseases 70
Pulmonary Disease, Chronic Obstructive 67
Lung Diseases, Obstructive 55
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Clinical Trial Locations for Fluticasone Propionate

Trials by Country

Trials by Country for Fluticasone Propionate
Location Trials
Germany 165
Canada 98
United Kingdom 75
Italy 72
Argentina 58
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Trials by US State

Trials by US State for Fluticasone Propionate
Location Trials
California 83
Texas 81
Florida 76
South Carolina 73
North Carolina 69
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Clinical Trial Progress for Fluticasone Propionate

Clinical Trial Phase

Clinical Trial Phase for Fluticasone Propionate
Clinical Trial Phase Trials
Phase 4 88
Phase 3 89
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Fluticasone Propionate
Clinical Trial Phase Trials
Completed 228
Recruiting 25
Not yet recruiting 13
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Clinical Trial Sponsors for Fluticasone Propionate

Sponsor Name

Sponsor Name for Fluticasone Propionate
Sponsor Trials
GlaxoSmithKline 130
AstraZeneca 12
Boehringer Ingelheim 11
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Sponsor Type

Sponsor Type for Fluticasone Propionate
Sponsor Trials
Industry 277
Other 91
NIH 7
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